BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR-T COATED

    MDR report key: 1243041 · Received November 20, 2008

    Report

    Report Number
    1028232-2008-01486
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    June 19, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PACEMAKER COULD NOT BE INTERROGATED. THE PACEMAKER WAS SHIPPED TO THE MFR OF THE ELECTIONS MODULE AND WAS SUBSEQUENTLY ANALYZED DESTRUCTIVELY. THE ANALYSIS REVEALED A DAMAGED INTEGRATED CIRCUIT. THE QUALITY DOCUMENTS ACCOMPANYING THE PACEMAKER HAVE BEEN RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING PRODUCTION AND FINAL ACCEPTANCE TEST OF THIS PACEMAKER. DURING PRODUCTION AT BIOTRONIK, THE PACEMAKER WAS FULLY FUNCTIONAL. IN SUMMARY, THE ANALYSIS IDENTIFIED A DAMAGED INTEGRATED CIRCUIT AS THE ROOT CAUSE OF THE CLINICAL OBSERVATION. IT IS UNK WHETHER THE PACEMAKER WAS SUBJECTED TO STRONG EXTERNAL FIELD DURING STORAGE OR DURING IMPLANTATION.

    Description of Event or Problem · 1

    TWO DAYS POST IMPLANT, THE PACEMAKER COULD NOT BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR-T COATED PACEMAKER DXY BIOTRONIK GMBH AND CO. 349810

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization